Measurement of Anti-Müllerian Hormone (AMH), using assays such as the Beckman Coulter Access AMH assay*, has proven value as an aid in the evaluation of ovarian reserve.
Results obtained with the AMH assay on the DxI 9000 Immunoassay Analyzer† showed exemplary agreement with the predicate Access 2 analyzer, excellent accuracy and precision, and remarkable sensitivity capabilities.
The study demonstrated:
- A limit of quantitation (LoQ) between 0.001 and 0.003 ng/mL on the DxI 9000 analyzer, representing up to 20-fold improvement in sensitivity compared with AMH assays on other automated immunoassay analyzers
- Excellent accuracy of DxI 9000 analyzer relative to the predicate device Access 2 (slope of 1.02 with bias ≤ 2% at key medical decision points)
- 20-day imprecision across the measuring interval (2-5% CVs), and linearity (range of -3 to 9% non-linearity)
The Beckman Coulter Access AMH assay on the DxI 9000 analyzer showed good linearity and imprecision results with exceptional low-end performance, with up to 20-fold improvement in comparison with existing AMH immunoassays.
At Beckman Coulter, we are committed to revolutionizing the next generation in immunoassay testing with precision and sensitivity to drive innovations, advance medical insights, and enhance diagnostic availability.